Psilocybin-assisted therapy for reducing alcohol intake in patients with alcohol use disorder: protocol for a randomised, double-blinded, placebo-controlled 12-week clinical trial (The QUANTUM Trip Trial)
Introduction Alcohol use disorder is a difficult-to-treat psychiatric disorder and a major burden on public health. Existing treatment efficacy is moderate, and relapse rates are high. Preliminary findings suggest that psilocybin, a psychedelic compound, can safely and reliably occasion highly meani...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2022-10-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/10/e066019.full |
| _version_ | 1811235207066419200 |
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| author | Claus Thorn Ekstrøm Patrick MacDonald Fisher Gitte Moos Knudsen Dea Siggaard Stenbæk Anders Fink-Jensen Mathias Ebbesen Jensen Tobias Søgaard Juul |
| author_facet | Claus Thorn Ekstrøm Patrick MacDonald Fisher Gitte Moos Knudsen Dea Siggaard Stenbæk Anders Fink-Jensen Mathias Ebbesen Jensen Tobias Søgaard Juul |
| author_sort | Claus Thorn Ekstrøm |
| collection | DOAJ |
| description | Introduction Alcohol use disorder is a difficult-to-treat psychiatric disorder and a major burden on public health. Existing treatment efficacy is moderate, and relapse rates are high. Preliminary findings suggest that psilocybin, a psychedelic compound, can safely and reliably occasion highly meaningful experiences that may spur a positive change in drinking behaviour when administered in a therapeutic context. However, the efficacy of a single psilocybin administration and its potential neurobiological underpinnings still remain unknown.Methods and analysis To establish efficacy, we will investigate the effects of psilocybin-assisted therapy versus placebo in a randomised, double-blinded, placebo-controlled 12-week clinical trial. Ninety treatment-seeking patients, aged 20–70 years, diagnosed with alcohol use disorder will be recruited from the community via advertisement and referrals from general practitioners or specialised treatment units. The psilocybin or placebo will be administered in accordance with a protocol for psychological support before, during and after the dosing. Outcome assessments will be carried out 1, 4, 8 and 12 weeks postdosing. The primary outcome is reduction in the percentage of heavy drinking days from baseline to follow-up at 12 weeks. Key secondary outcomes are as follows: (1) total alcohol consumption, (2) phosphatidyl-ethanol, an objective biomarker for alcohol, (3) plasma psilocin, the active metabolite, to establish a possible therapeutic range, (4) the acute subjective drug experience as a possible predictor of treatment outcome and (5) neuronal response to alcohol cues and cognitive flexibility within corticostriatal pathways by use of functional MR brain imaging 1-week postdosing.Ethics and dissemination Ethical approval has been obtained from the Committee on Health Research Ethics of the Capital Region of Denmark (H-20043832). All patients will be provided oral and written information about the trial before screening. The study results will be disseminated by peer-review publications and conference presentations.Trial registration number EudraCT 2020-000829-55 and NCT05416229. |
| first_indexed | 2024-04-12T11:47:07Z |
| format | Article |
| id | doaj.art-60ddd264178b4d84920f8ff4f9934e7f |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-04-12T11:47:07Z |
| publishDate | 2022-10-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-60ddd264178b4d84920f8ff4f9934e7f2022-12-22T03:34:19ZengBMJ Publishing GroupBMJ Open2044-60552022-10-01121010.1136/bmjopen-2022-066019Psilocybin-assisted therapy for reducing alcohol intake in patients with alcohol use disorder: protocol for a randomised, double-blinded, placebo-controlled 12-week clinical trial (The QUANTUM Trip Trial)Claus Thorn Ekstrøm0Patrick MacDonald Fisher1Gitte Moos Knudsen2Dea Siggaard Stenbæk3Anders Fink-Jensen4Mathias Ebbesen Jensen5Tobias Søgaard Juul6Department of Public Health, Section of Biostatistics, University of Copenhagen, Copenhagen, DenmarkDepartment of Neurology and Neurobiology Research Unit, Copenhagen University Hospital, Copenhagen, DenmarkDepartment of Neurology and Neurobiology Research Unit, Copenhagen University Hospital, Copenhagen, DenmarkDepartment of Neurology and Neurobiology Research Unit, Copenhagen University Hospital, Copenhagen, DenmarkPsychiatry Centre Copenhagen, Copenhagen University Hospital, Copenhagen, DenmarkPsychiatry Centre Copenhagen, Copenhagen University Hospital, Copenhagen, DenmarkPsychiatry Centre Copenhagen, Copenhagen University Hospital, Copenhagen, DenmarkIntroduction Alcohol use disorder is a difficult-to-treat psychiatric disorder and a major burden on public health. Existing treatment efficacy is moderate, and relapse rates are high. Preliminary findings suggest that psilocybin, a psychedelic compound, can safely and reliably occasion highly meaningful experiences that may spur a positive change in drinking behaviour when administered in a therapeutic context. However, the efficacy of a single psilocybin administration and its potential neurobiological underpinnings still remain unknown.Methods and analysis To establish efficacy, we will investigate the effects of psilocybin-assisted therapy versus placebo in a randomised, double-blinded, placebo-controlled 12-week clinical trial. Ninety treatment-seeking patients, aged 20–70 years, diagnosed with alcohol use disorder will be recruited from the community via advertisement and referrals from general practitioners or specialised treatment units. The psilocybin or placebo will be administered in accordance with a protocol for psychological support before, during and after the dosing. Outcome assessments will be carried out 1, 4, 8 and 12 weeks postdosing. The primary outcome is reduction in the percentage of heavy drinking days from baseline to follow-up at 12 weeks. Key secondary outcomes are as follows: (1) total alcohol consumption, (2) phosphatidyl-ethanol, an objective biomarker for alcohol, (3) plasma psilocin, the active metabolite, to establish a possible therapeutic range, (4) the acute subjective drug experience as a possible predictor of treatment outcome and (5) neuronal response to alcohol cues and cognitive flexibility within corticostriatal pathways by use of functional MR brain imaging 1-week postdosing.Ethics and dissemination Ethical approval has been obtained from the Committee on Health Research Ethics of the Capital Region of Denmark (H-20043832). All patients will be provided oral and written information about the trial before screening. The study results will be disseminated by peer-review publications and conference presentations.Trial registration number EudraCT 2020-000829-55 and NCT05416229.https://bmjopen.bmj.com/content/12/10/e066019.full |
| spellingShingle | Claus Thorn Ekstrøm Patrick MacDonald Fisher Gitte Moos Knudsen Dea Siggaard Stenbæk Anders Fink-Jensen Mathias Ebbesen Jensen Tobias Søgaard Juul Psilocybin-assisted therapy for reducing alcohol intake in patients with alcohol use disorder: protocol for a randomised, double-blinded, placebo-controlled 12-week clinical trial (The QUANTUM Trip Trial) BMJ Open |
| title | Psilocybin-assisted therapy for reducing alcohol intake in patients with alcohol use disorder: protocol for a randomised, double-blinded, placebo-controlled 12-week clinical trial (The QUANTUM Trip Trial) |
| title_full | Psilocybin-assisted therapy for reducing alcohol intake in patients with alcohol use disorder: protocol for a randomised, double-blinded, placebo-controlled 12-week clinical trial (The QUANTUM Trip Trial) |
| title_fullStr | Psilocybin-assisted therapy for reducing alcohol intake in patients with alcohol use disorder: protocol for a randomised, double-blinded, placebo-controlled 12-week clinical trial (The QUANTUM Trip Trial) |
| title_full_unstemmed | Psilocybin-assisted therapy for reducing alcohol intake in patients with alcohol use disorder: protocol for a randomised, double-blinded, placebo-controlled 12-week clinical trial (The QUANTUM Trip Trial) |
| title_short | Psilocybin-assisted therapy for reducing alcohol intake in patients with alcohol use disorder: protocol for a randomised, double-blinded, placebo-controlled 12-week clinical trial (The QUANTUM Trip Trial) |
| title_sort | psilocybin assisted therapy for reducing alcohol intake in patients with alcohol use disorder protocol for a randomised double blinded placebo controlled 12 week clinical trial the quantum trip trial |
| url | https://bmjopen.bmj.com/content/12/10/e066019.full |
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